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Title: Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma
Authors: Maruyama, Dai
Nagai, Hirokazu
Fukuhara, Noriko
Kitano, Toshiyuki
Ishikawa, Takayuki
Shibayama, Hirohiko
Choi, Ilseung
Hatake, Kiyohiko
Uchida, Toshiki
Nishikori, Momoko  kyouindb  KAKEN_id
Kinoshita, Tomohiro
Matsuno, Yoshihiro
Nishikawa, Tomoaki
Takahara, Satoko
Tobinai, Kensei
Author's alias: 北野, 俊行
Keywords: Efficacy
ibrutinib
mantle cell lymphoma
overall response rate
safety
Issue Date: Dec-2016
Publisher: Wiley-Blackwell
Journal title: Cancer Science
Volume: 107
Issue: 12
Start page: 1785
End page: 1790
Abstract: In this multicenter, single-arm, phase II study, the efficacy and safety of ibrutinib were examined in Japanese patients with relapsed or refractory mantle cell lymphoma (MCL). Patients (age ≥20 years) with relapsed or refractory MCL who had progressed after receiving at least one prior treatment regimen, were enrolled. Patients were treated with oral ibrutinib (560 mg once daily; 28-day cycle) until disease progression (or relapse), unacceptable toxicity, or study end. The primary end-point was overall response rate. Secondary end-points included duration of response (DOR), time to response, progression-free survival (PFS), overall survival, and safety. Of the 16 patients who received treatment, 5 patients discontinued the study (progressive disease, 4; sepsis, 1). Median duration of ibrutinib exposure was 6.5 months (range, 2.8–8.3 months). The overall response rate was 87.5% (90% confidence interval, 65.6–97.7; complete response = 2 [12.5%]; partial response = 12 [75.0%]). Median time to response for all responders (n = 14) was 1.8 months (range, 0.7–5.3 months). The median DOR and PFS were not estimable due to censoring (range: DOR, 1.1–6.4+ months; PFS, 2.8–8.0+ months). Overall survival data were immature due to the limited observation period. A total of 8/16 patients (50%) had at least one grade 3 adverse event (AE), and 5 (31.3%) patients reported serious AEs. The most commonly reported AEs were diarrhea and stomatitis (37.5% each), platelet count decrease (31.3%), and anemia (25%). Overall, orally administered single agent ibrutinib was efficacious with an acceptable safety profile in Japanese patients with relapsed or refractory MCL. Clinical trial registration NCT02169180 (ClinicalTrials.gov).
Rights: © 2016 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is noncommercial and no modifications or adaptations are made.
URI: http://hdl.handle.net/2433/218937
DOI(Published Version): 10.1111/cas.13076
PubMed ID: 27616553
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